Syringe - IV Access Locking Device

ABSTRACT

A safety device is described wherein drug delivery systems and methods involve associating unique keys to patients that prevent the interconnection between a drug delivery device and non-complimentary patient key. Medication in a drug delivery device intended for a patient may only be accessed via a particular unique key associated with the intravenous access device of that patient.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority under 35 U.S.C. §119(e) to U.S.Provisional Application No. 61/774,673, filed Mar. 8, 2013, thedisclosures of which are incorporated herein by reference in theirentirety.

TECHNICAL FIELD

An aspect of the present invention relates generally to a drug deliverysafety device having a locking element attachable a drug delivery deviceand a keying element attachable to an intravenous access device of apatient. In one embodiment, the locking element has at least one flangewith a plurality of configurable cutouts to provide a plurality ofnotches in a receiving pattern to a keying element attached to avascular access device having a plurality of configurable projectingtabs to provide a complementary fit with the receiving pattern of thelocking element. In another embodiment, the locking element has a keywaythat is positioned to correspond with a complementary key tab on thekeying element. In yet another embodiment, the locking element has oneor more detachable interference ribs that may be selectively configuredto form gaps in a pattern to correspond with a complementary pattern ofdetachable protrusions on the keying element.

BACKGROUND

Misadministration of medication is a significant problem whereapproximately 59% of all injectable errors occur at administration, andintravenous (IV) drugs account for 75% of injectable preventable adversedrug events in acute care settings. The complexity of parenteralmedication administration and increased intolerance of the complicationsthat result from improper medication delivery, create demand for devicesthat make drug delivery safe and efficient. Safety has been addressed inthe market from many perspectives including needles, and fluidcontainment. A simple solution to help ensure medications are correctlydelivered to patients via the parenteral route is not currentlyaddressed.

Different size Luer connectors are passive approaches, but do notprovide a unique patient-specific key. Active approaches that requireinformation technology infrastructure such as radio frequencyidentification (RFID) tags and bar codes address the problem, but theseactive approaches require a significant investment for theirimplementation. Further, there is concern that due to the wide adoptionof the Luer lock in many applications, drugs can be administered throughimproper ports. For example, anesthesia injections intended for thespine, IV injections, and gasses can all employ the same connections fordelivery.

Thus, there is a need for a passive approach that provides a uniquepatient-specific key to prevent or reduce the improper administration ofparenteral medications.

SUMMARY

One aspect of the present invention pertains to a drug delivery safetydevice comprising a locking element having a body with a proximal endand a distal end, the proximal end of the locking element beingattachable a drug delivery device and the distal end of the lockingelement having at least one flange with a plurality of mechanicallyconfigurable sections to provide a patient specific pattern of receivingopenings. The device also comprises a keying element having a proximalend and distal end, the proximal end may be attachable to a vascularaccess device, and the distal end may have a plurality of mechanicallyconfigurable engagement members. The drug delivery device securelyconnects to the vascular access device when the engagement member of thekeying element is configured to provide a complementary fit with thepatient specific pattern of receiving openings of the locking element.

In one or more embodiments, the drug delivery device may be a syringe,intravenous catheter connector, IV bag spike, or point ofinterconnection in an IV administration set. The syringe may have a tiplocated in the body of the locking element.

In one or more embodiments, the mechanically configurable sections maycomprise a plurality of configurable notches. The plurality ofconfigurable notches may incorporate predetermined geometrical shapesand may be located on the periphery of the flange. An end user mayconfigure a selected number of notches to create a locking element todistinguish the route of administration. The route of administration maybe parenteral, enteral or anesthesia.

The locking element may have two flanges. The one or more flange mayhave a circular shape.

In one or more embodiments, an end user may remove, move, rotate,reshape, melt, reposition, uncover, or puncture one or more of theplurality of mechanically configurable sections.

The locking element may be configured to be patient specific,application specific or drug specific. In one or more embodiments, thelocking element may also comprise a sensor. The keying element may berotatable and/or spring-loaded. In one or more embodiments, the keyingelement may further comprise a sensor. The locking element and keyingelement may be associated with only one patient or small number ofpatients of a larger patient population.

The engagement members may comprise removable tab-like projections toidentify an individual patient, application or drug type.

In one or more embodiments, the drug delivery safety device may alsocomprise a visual indicator for drug family identification. The drugdelivery safety device may also comprise a master keying element capableof unlocking two or more individualized locking elements.

Another aspect of the present invention pertains to a drug deliverysafety device comprising a locking element comprises a housing having acurved-shaped outer sidewall with a flat ledge on a top portion, aninner sidewall having an open central cavity, and a back wall locatedbetween the inner and outer sidewalls. The inner sidewall may have adistal end and a proximal end, the distal end may have one or moredetenting ribs protruding radially outward around the outercircumference, and the proximal end of the inner sidewall may have oneor more inwardly protruding tabs. The device also comprises a needlelessIV connector disposed in the open central cavity of the inner sidewalland held between the one or more inwardly protruding tabs of the innersidewall and a first insert having an open distal end and an openproximal end; a sidewall extending between the open distal end and theopen proximal end, the sidewall on the distal end may have more than onedetents on an inside circumference of the sidewall protruding radiallyinward toward the central axis, the one or more detents of the firstinsert having a complimentary fit with the one or more detenting ribs ofthe housing when the first insert is place into the housing. A keywaymay be cut into the sidewall on the proximal end of the first insert tocorrespond with an individual patient. A keying element may comprise ahousing having a outer sidewall having a curved shape with a flat ledgeon a top portion, the outer sidewall having an open distal end and aproximal end having a back wall, an inside surface of the proximal endof the outer sidewall having one or more detents located around thecircumference of the inside surface of the proximal end of the outersidewall protruding radially outward, the back wall may have an opencentral cavity formed by a second inner wall. The device also comprisesa second insert having an open distal end and an open proximal end; asidewall extending between the open distal end and the open proximalend, the sidewall on the proximal end may have one or more detentingribs on an outer circumference of the sidewall protruding radiallyoutward, the one or more detenting ribs of the second insert may have acomplimentary fit with the one or more detent of the housing when thesecond insert is place into the housing, a key tab projecting radiallyinward from the distal end of the second insert toward the central axis.The outer sidewall of the keying element may have a diameter smallerthan the outer diameter of the outer sidewall of the locking element toenable the keying element to slide into the locking element when thekeyway of the locking element is aligned with the tab projectingradially inward from the distal end of the second insert.

In one or more embodiments, the locking element may be placed on a drugdelivery device. The drug delivery device may be a syringe. In one ormore embodiments, the keying element may be placed on an intravenousaccess device. In one or more embodiments, the housing of the lockingelement may also be imprinted with numerical values assigned todifferent positions of the keyway. In one or more embodiments, thehousing of the keying element may be imprinted with numerical valuesassigned to different positions of the key tab. The position of thekeyway and key tab may be patient specific, specific to a route ofadministration, or specific to a drug class. In one or more embodiments,the device may further comprise a visual indicator for drug familyidentification.

Another aspect of the present invention pertains to a drug deliverysafety device comprising a locking element comprises a housing having anouter sidewall, an inner sidewall, a back wall located between the innerand outer sidewalls. The outer sidewall may have a curved shape with aflat ledge on a top portion, the inner sidewall creating an open centralcavity. The inner sidewall has a distal end and a proximal end. Theinside surface of the curved portion of the outer sidewall may have oneor more detachable interference ribs protruding radially outward towardsthe central axis. The proximal end of the inner sidewall may have one ormore inwardly protruding tabs. The device may also comprise a needlelessIV connector disposed in the open central cavity of the inner sidewalland held between the one or more inwardly protruding tabs of the innersidewall. The device may also comprise a keying element comprising ahousing having a sidewall having a curved shape with a flat ledge on atop portion, the sidewall may have an open distal end and a proximal endmay have a back wall. One or more detachable protrusions may extendradially outward along an outer circumference of the curved portion ofthe sidewall. The back wall may have an open central cavity. The one ormore detachable interference ribs of the locking element may beconfigurable to form gaps in a pattern to correspond with an individualpatient and the detachable protrusions of the keying element beingconfigurable to complement the gaps formed on the locking element. Thesidewall of the keying element may have a diameter smaller than thediameter of the outer sidewall of the locking element to enable thekeying element to slide into the locking element when the gaps of thelocking element are aligned with the protrusions of the keying element.

In one or more embodiments, the locking element may be placed on a drugdelivery device and the keying element may be placed on an intravenousaccess device. In one or more embodiment, the drug delivery device maybe a syringe. In one or more embodiments, the housing of the lockingelement may be imprinted with numerical values assigned to differentdetachable interference ribs and the housing of the keying element maybe imprinted with numerical values assigned to different detachableprotrusions.

The position of the protrusions on the keying element may be patientspecific, specific to a route of administration or specific to a drugclass. The device may also include a visual indicator for drug familyidentification.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows one embodiment of the locking element of the drug deliverysafety device of the present invention;

FIG. 2 shows one embodiment of the keying element of the drug deliverysafety device of the present invention;

FIG. 3 shows one embodiment of a rotatable keying element of the drugdelivery safety device of the present invention;

FIG. 4 shows an exemplary embodiments of various notch designs of thelocking element;

FIG. 5 shows one embodiment of the rotary adjusted keying system of thedrug delivery safety device of the present invention;

FIG. 6 shows one embodiment of the rotary adjustment bench tool of thedrug delivery safety device of the present invention;

FIG. 7 shows another embodiment of the rotary adjustment bench tool ofthe drug delivery safety device of the present invention;

FIG. 8 shows yet another embodiment of the rotary adjustment tool of thedrug delivery safety device of the present invention;

FIG. 9 shows one embodiment of the cut adjusted keying system of thedrug delivery safety device of the present invention;

FIG. 10 shows one embodiment of the locking element and keying elementof the cut adjusted keying system of the drug delivery safety device ofthe present invention;

FIG. 11 shows one embodiment of the cutter for a cut adjusted keyingsystem of the drug delivery safety device of the present invention; and

FIG. 12 shows another embodiment of the cutter for a cut adjusted keyingsystem of the drug delivery safety device of the present invention.

DETAILED DESCRIPTION

Before describing several exemplary embodiments of the invention, it isto be understood that the invention is not limited to the details ofconstruction or process steps set forth in the following description anddrawings. The invention is capable of other embodiments and of beingpracticed or carried out in various ways. Additionally, in thefollowing, items which are substantially the same across the variousembodiments are given the same reference numbers.

In general, the present invention describes a passive safety device thatcreates a lock and key mechanism between a syringe, intravenous catheterconnector, IV bag spike, or point of interconnection in an IVadministration set and the point of IV access (e.g., BD Q-Syte™ LuerAccess Split Septum). It is envisioned that the lock mechanism is“configured” or “cut” at the pharmacy, or where IV medications (e.g.,syringes, bags, lines for pumps), or fluid source, are prepared. Thelock is part of the fluid source. The terms “configured” or“configurable” are defined as elements or mechanisms that may beremoved, moved, rotated, reshaped, melted, repositioned, uncovered, orpunctured.

Cut Flange

In one embodiment, as shown in FIG. 1, a drug delivery safety device 10is provided having a locking element 20 having a body 22 with an openproximal end 24 and an open distal end 26, a sidewall 28 extending fromthe open proximal end to the open distal end, the proximal end of thesidewall having one or more adherence element 30 to attach the drugsafety device to a drug delivery device 50, e.g. a syringe, intravenouscatheter connector, IV bag spike, or point of interconnection in an IVadministration set. Adherence element 30 may comprise any method ofadherence known to a person of skill in the art, including but notlimited to, interference fit, adhesives, locking tab, an indentation toattach the locking mechanism, or an integral or molded part to attachthe drug safety device to a drug delivery device. As shown in FIG. 1,the one or more adherence elements 30 prevent removal of the safetydevice from the drug delivery device after the locking element has beenattached to the drug delivery device. The distal end having at least oneflange 32 with a plurality of mechanically configurable sections 344 toprovide a plurality of openings or notches 36 in a receiving pattern. Inone or more embodiments, mechanically configurable sections 34 may be inthe form of cutouts. Configurable notches are defined as notches thatmay be removed, moved, rotated, reshaped, melted, repositioned,uncovered, or punctured. In one or more embodiments, a set ofconfigurable notches or openings can be cut into the periphery of theflange of the locking element in a particular pattern that match thecorresponding keying element. FIG. 1 shows a flange having pre-scorednotches which may be selectively removed, moved, rotated, reshaped,melted, repositioned, uncovered, or punctured to provide a desiredpattern of notches or openings.

In one embodiment, as shown in FIG. 2, a keying element 40 having aproximal end 42 and distal end 44, said proximal end 42 attachable to avascular access device 48, and the distal end 44 having a flange with aplurality of configurable engagements members 46 to provide acomplementary fit with the receiving pattern of the locking element. Inone or more embodiments, the configurable engagement members may be inthe form of projecting tabs. The flange with a plurality of configurableengagements members surround the intravenous access port. FIG. 2 showsthe IV access key, starting from a blank keying element having a fullset of configurable engagements members 46 for coding patientidentification, application or drug type, or access points to aspecifically keyed device wherein a sequence of engagements members orprojecting tabs have been selectively configured to provide acomplementary fit with a receiving pattern of a corresponding lockingelement.

In one or more embodiments, either the distal end of the locking elementor the proximal end of the keying element have a plurality ofmechanically configurable sections or cutouts to provide a plurality ofnotches or openings in a receiving pattern, and the corresponding distalend of the locking element or proximal end of the connector have aplurality of configurable engagements members or projection tabs toprovide a complementary fit with the receiving pattern. In one or moreembodiments, the locking element is applied to the IV access device, andthe keying element is applied to the drug delivery device. In one ormore embodiments, the keying element is applied to the IV access device,and the locking element is applied to the drug delivery device.

For illustration, the locking element 20 is shown in FIG. 1 attached toa syringe barrel serving as a drug delivery device 50.

The sidewall 28 of the locking element is coaxially disposed around themedical delivery device 50 and extends toward the open distal end of themedical delivery device. The distally extending sidewall defines anannular space 21 between the distally extending wall and the medicaldelivery device. In one or more embodiments, the annular space isconfigured or shaped to receive a keyed luer access device 60. In one ormore alternative embodiments, the distally extending wall is shaped orconfigured to engage the keyed luer access device. In the embodimentsshown in FIG. 1, the distally extending sidewall 22 includes an insidesurface which is shaped to form a fluid-tight engagement with the IVaccess device.

The locking element 20, including the distally extending sidewall andthe annular space, attached to the medical delivery device is shaped toprevent attachment of the medical delivery device to an unintended orincompatible IV access component or other device, including standard IVroute-accessing devices, including, without limitation, blunt cannulasplit-septum, luer access mechanical valves, luer access mechanicalvalves with positive displacement, luer access split-septa.

FIG. 3 shows an exemplary design of a rotating keying element whereinthe plurality of configurable projection tabs are provided on a flange60 having a central opening 62. An elastomeric ring 64 may placed in thecentral opening. The flange 60 is subsequently inserted into a grooveformed in the body of the intravenous access device 44. The rotatingkeying element allows for the use of the locking threads of the Luerconnection. Specifically, the rotating keying element allows forinsertion of the keying element into the locking element, whilepermitting conventional function of the Luer lock by rotating thesyringe or interconnection. The flange may be be spring loaded with aspring wire to return the keying element to a desired starting position.

FIG. 4 shows exemplary keying elements with a variety of notch designswhich may be utilized to distinguish between different types ofintravenous applications, for example, standard IV, chemotherapy andanesthesia. In one or more embodiments, various shapes, e.g.rectangular, may be used to distinguish different drug classes toprovide the advantage of being able to utilize the same patient code andcorresponding lock and key cutting devices, while adding additionalprotection for different administration sites.

In one or more embodiments, the locking element preferably has metallocking tabs that are angled into, and point towards the drug deliverydevice, e.g. syringe barrel, that prevent removal once applied. Manyoptions exist to prevent removal of the drug delivery safety device fromthe drug delivery device, including adhesives, plastic features, etc.The open distal end of the drug delivery device, e.g. syringe tip, isdisposed within the cylindrical portion of the locking element toprevent bypassing the lock. Other lock and key designs could also beemployed besides flange-like designs. For example, it is envisioned thatthe adherence elements may be disposed on an internal or external wallof a cylinder or other shape device. Many lock designs can be imaginedthat would prevent an interconnection, but the most important feature isthe ability to code the interconnection between the locking element andthe keying element. If the lock and key are not complementary, then thehealth care provider will not be able to insert the fluid source intothe IV access site. This decreases the chances that a patient willreceive drugs intended for another patient. Although the system can beutilized with any fluid interconnection system, the primary applicationwould allow the continued use of the Luer lock, but add a safety lockoutfeature to the system. In one or more embodiments, lock and keyingmethods that prevent or brake the syringe plunger from being depressedare also contemplated. However, these mechanisms are not preferred dueto the large variation in plunger dimensions.

It is desirable to minimize the likelihood of forced interconnection.The term coding scheme is the method by which locks are keyed tospecific patients, drug families, or access points. This is implementedby selecting locations of tabs and notches, their shapes, and thealgorithm used to cut them. If improper coding schemes are selected, itcan be imagined that situations exist where there might only be oneprojection tab blocking the connection. Therefore, any scheme selectedshould allow for sufficient projection tabs on the keying element toblock the interconnection with the notch on the locking element.

In one or more embodiments, three or more projection tabs are alwaysdistributed around the flange of the keying element. The shape of theflanges can be selected to more easily indicate how the lock and keyshould be aligned. This can be through shape selection (e.g., “D-shape”)or adding features like notches, colors, or other indicators of properalignment. The locking element may be in various shapes, including butnot limited to, cylindrical, rectangular, triangular, etc. The flange ofthe locking element may also be in various shapes, including but notlimited to, circular, rectangular, triangular, etc. Keying tabs andcorresponding notch features can have various incompatible shapes (pieslice shapes are shown, as well as rectangular shapes, but any set ofmutually locking shapes can be employed). Key tabs and correspondingnotch features can be on the periphery or anywhere within the flange.The key tabs and corresponding notch features can also be multi-layered,in the case where there would be more than one flange which can furtherprevent forced connections.

In one or more embodiments, a simple coding scheme would allow for anassignment of a code to the last two digits of the patients ID, orsocial security number. This would reduce the risk of misadministrationassuming these two digits are randomly distributed in the hospital. Manyother coding schemes are envisioned, as are known in the field ofinformation theory.

In one or more embodiments, the lock and key may also be color coded toidentify drug families, such as anesthesia drugs, chemotherapy, orantibiotics. These colors would provide visual reminders as well asmatching drug class keys.

The drug delivery safety device of the present invention can beimplemented either as a mandatory lock or as an added safety feature,depending on the clinical environment and specific needs. In mandatorylock situations, all non-lock devices cannot contact the IV accessdevice. In one embodiment of mandatory lock mode, a locking element canbe implemented where only one corresponding keying element preventsaccess to the drug delivery device. In the case of the mandatory lockingscheme, a universal or master keying element can be designed thatdeactivates the locking element without being specifically keyed for apatient. This would allow for rapid access in clinical situations wheretime is of the essence. In added safety situations, conventional devicescan still contact the access device, for example in the case ofemergency, or if a drug dose comes from an area of the hospital that isnot participating in the locking system. However, the system stillprovides added safety for doses coming from sources that are using thelocking technology.

Lock and key cutting equipment, as well as interconnections withhospital information technology systems to ensure and automate propercoding is also contemplated.

In another embodiment of the present invention, a locking element notchcutter (not shown) and keying element tab cutter (not shown) isprovided. The lock and key cutters would be used to customize blanks(e.g., no notches cut, no tabs removed) to make them patient specific.The lock cutter could be used as a step in drug preparation process inthe pharmacy, for example. The key cutter would be employed by the IVteam or floor nurse for the patient side of the circuit. These systemscould range from purely mechanical, to automated, integrated systemsthat link to other patient, data, care management systems.

In one or more embodiments, one or more sensors may be placed on thelocking element and keying element that detect interconnections andreport these to another information system for automated medical recordsor monitoring purposes. Sensors could also detect stress and strain,indicating improper forced connections, or even incorrect connectionsthat were prevented.

In one or more embodiments, the keying element may be prepared by thepatients' care providers, or the IV team. In one or more embodiments,the locking element may be prepared by the pharmacy.

Rotary—Adjustable Key and Keyway

In another embodiment of the present invention, as shown in FIG. 5, adrug delivery safety device 10 is provided comprising a locking element220 having a housing 70 having an outer sidewall 72, an inner sidewall74, a back wall 76 located between the inner and outer sidewalls. Theouter sidewall 72 has a curved shape with a flat ledge on a top portion78. The inner sidewall 72 creates an open central cavity 79 to house aneedleless IV connector 80 e.g. a luer access split septum stand alonedevice. The inner sidewall has a distal end 82 and a proximal end 84,the distal end having one or more detenting ribs 86 protruding radiallyoutward from the central axis located around the outer circumference.The proximal end 84 of the inner sidewall has one or more inwardlyprotruding tabs 88. A needleless IV connector may be disposed in theopen central cavity 79 of the inner sidewall and held between the one ormore inwardly protruding tabs 88 of the inner sidewall. A first insert90 has an open distal end 92 and an open proximal end 94, along with asidewall 96 that extends between the open distal end 92 and the openproximal end 94. The sidewall 96 on the distal end includes one or moredetents 98 on an inside circumference of the sidewall 96 protrudingradially inward toward the central axis. The one or more detents 98 ofthe first insert 90 has a complimentary fit with the one or moredetenting ribs 86 of the housing when the insert is place into thehousing. A keyway 100 is cut into the sidewall 96 on the proximal end94.

The drug delivery safety device 10 further includes a keying element 110comprising a housing 112 having a outer sidewall 114 having a curvedshape with a flat ledge 116 on a top portion. The outer sidewall 114 hasan open distal end 118 and a proximal end 120 having a back wall 122. Aninside surface of the proximal end of the outer sidewall having one ormore detents 124 protruding radially outward from the central axislocated around the circumference of the inside surface of the proximalend of the outer sidewall. The back wall 122 includes an open centralcavity 126 formed by a second inner wall 128 to house a second insert130.

The second insert 130 includes an open distal end 132, an open proximalend 134 and a sidewall 136 extending between the open distal end and theopen proximal end. The sidewall 136 on the proximal end having one ormore detenting ribs 138 on an outer circumference of the sidewallprotruding radially outward. The one or more detenting ribs 138 of theinsert have a complimentary fit with the one or more detents 124 of thehousing when the insert is place into the housing. A key tab 140projects radially inward from the distal end of the second insert towardthe central axis. The outer sidewall of the keying element having adiameter smaller than the outer diameter of the outer sidewall of thelocking element 220 to enable the keying element to slide into thelocking element 220 when the keyway of the locking element is alignedwith the tab projecting radially inward from the distal end of thesecond insert.

The keyway 100 on the locking element and the tab 140 projectingradially inward from the distal end of the second insert of the keyingelement are aligned to one another by rotating the keyway or tab intoposition prior to sliding the locking element and keying element so thatthe detenting ribs (86, 138) engage the corresponding detents (98, 124).Each individual patient is assigned a specific positioning for thekeyway 100 of the locking element and the protruding tab on the keyingelement.

With the keyway and key tab being freely rotatable within the housing,an infinite number of relative positions of angular adjustment areafforded. Once the keyway and key tabs are rotationally adjusted into acomplementary pattern, the inserts can be fixed in a selected positionof adjustment and maintained by fixing the detents on to the detentingribs of the corresponding locking element and keying element.

Upon assembly, the needleless IV connector 80 is positioned into theopen central cavity 79 of the inner sidewall of the locking element 220and inserted into the central cavity until the needleless IV connector80 is disposed in the open central cavity of the inner sidewall and heldbetween the one or more inwardly protruding tabs 88 of the innersidewall of the locking element. The keyway 100 of the locking elementis rotated into a specific position that has been assigned to theindividual patient and the first insert 90 is then inserted into thehousing of the locking element so that one or more detents 98 of thesidewall on the distal end on an inside circumference of the sidewallprotruding radially inward toward the central axis engages the one ormore detenting ribs 86 of the housing when the insert is place into thehousing in a complimentary fit. The locking element 220 is nowassembled. The locking element is placed onto a drug delivery device orfluid container to restrict access to the drug delivery device or fluidcontainer.

Similarly the protruding key tab 140 of the keying element is rotatedinto a specific position that corresponds with the keyway 100 of thelocking element assigned to the individual patient. Once the protrudingtab 140 of the keying element is rotated into the specific assignedposition, the second insert 130 is then placed into the housing of thekeying element so that the one or more detenting ribs 138 of the secondinsert 130 engage the one or more detents 124 of the housing of thekeying element in a complimentary fit. The keying element is nowassembled. The keying element is placed onto an IV access device on thepatient.

In one more embodiments, as shown in FIGS. 6 and 7, the protruding keytab of the keying element and the keyway of the locking element may berotated into a specific position that corresponds with assigned to theindividual patient using a bench top tool 110 designed to provide torqueto rotate the key tab or keyway into a specific position. As shown inFIGS. 6 and 7, in one or more embodiments, the outer surface of thelocking element or keying element that comprises a base plane 120.Extending from a central region of the base plane 140 is a stem 142. Thestem 142 has at least one face so that it can impart torque to adjustthe keyway or key tab. The cross-sectional shape of the stem 142 may be,for example, hexagonal, rectangular, star-shaped, etc., with respect tothe base plane 140. As shown in FIG. 7, the position may be assigned anumerical value 120 that may be imprinted in the outside surface of theouter housing of the locking element and keying element so that it isvisible to the pharmacist and the medical care provider. In anotherembodiment, as shown in FIG. 8, the protruding key tab of the keyingelement and the keyway of the locking element may be rotated into aspecific position that corresponds with assigned to the individualpatient using a handheld rotary adjustment tool having a mechanical oroptical gear counter wherein the tool comprises two or more gears toadjust the position of the keyway and corresponding key tab.

To deliver medication from the drug delivery device into the IV accessdevice on the patient, the flat ledge 78 on a top portion of the lockingelement is aligned with the flat ledge 116 on a top portion of thekeying device. If the proper locking element 220 is delivered to thepatient, the keyway 100 of the locking element will also align with theprotruding key tab 140 of the keying element allowing the lockingelement 20 to properly engage the keying element 240 so the IV accessdevice 48 engages the needleless IV connector 80 of the locking elementthus allowing medication to flow from the drug delivery device to thepatient. However if the proper locking element is not delivered to thepatient, the keyway 100 of the locking element will not align properlywith the protruding key tab 140 of the keying element thus preventingthe locking element 220 to properly engage the keying element 40,thereby preventing the IV access device 48 to engages the needleless IVconnector 80 of the locking element thus preventing medication to flowfrom the drug delivery device to the patient. Thus, the locking elementis “keyed” to the complementary keying element by adjusting the radialorientation of keyway on the locking element placed on the drug deliverydevice to correspond with the radial orientation of the key tab on thekeying element placed on the patient's IV access device.

Each patient is provided a respective locking element and keying elementthat is unique to that patient. In one or more embodiments, the keyingelement may be physically associated with or affixed to the patient's IVaccess device. The keying element may be provided to the patient withthe identification bracelet.

An exemplary use of the safety device system is described as follows.First, a health care provider determines that a specific type and dosageof medication is required to be administered to the patient. Aprescription for this medication is sent to the pharmacy, which thenworks to fill the order. The pharmacy is provided with the keyinginformation assigned to the individual patient. The keyway 100 on thelocking element is adjusted at the pharmacy to correspond to the key tab140 of the keying element assigned to the individual patient. Thelocking element is then placed onto the drug delivery device or fluidcontainer to prevent access to the medication within the container ordevice by a non-complimentary patient keying element. Thereafter, thedevice or container can only be accessed by the key tab 140 or a masterkey by the health care provider at the time of administration to thepatient. Access to the medication within the drug delivery device orcontainer is thereby restricted.

The pharmacy provides the drug delivery device or container having thelocking element to the health care provider, who then physically bringsthe access restricted drug delivery device or container to the patient.In one or more embodiments, the health care provider may adjust thekeying element on the patient's IV access device to correspond to thekeyway on the locking element as adjusted at the pharmacy using a rotaryadjustment tool as described further in this application. Once thekeyway on the fluid container is aligned with the key of the patient'sIV access device, the medication within the container may be accessedand administered to the patient.

In one or more embodiments, only the patient's keying element may beused to access the locking element on the fluid container. Suchrestrictive access, however, may prove inconvenient or even dangerous ifthe keying element is unavailable for a variety of reasons. For example,if the access restricted fluid container is brought to the patient andthe key cannot be accessed or has been discarded for some reason, thenneither the patient nor the health care provider will be able to accessthe medication. Alternatively, in medical emergencies, the keyingelement may not be readily at hand when time is at a premium. As aresult, in another embodiment of the present invention, a master keyingelement that is capable of unlocking all classes of locking element maybe provided or given to any suitable member of the health care providerteam.

Although the above embodiments are illustrated utilizing a limitednumber of keyways and corresponding key tab, it should be clear that anynumber of keyways and corresponding key tabs may be employed. Moreover,although the above embodiments provide a single unique key to eachpatient, such a strict one-to-one correlation is not necessarilyrequired.

Rotary—Cut

In yet another embodiment of the present invention, as shown in FIG. 9,a drug delivery safety device is provided comprising a locking element320 having a housing having an outer sidewall 160, an inner sidewall162, a back wall 164 located between the inner and outer sidewalls; theouter sidewall 162 having a curved shape with a flat ledge 166 on a topportion, the inner sidewall creating an open central cavity 168 to housea needleless IV connector 180 e.g. a luer access split septum standalone device. The inner sidewall 162 having a distal end 170 and aproximal end 172, the circumference of the inside surface of the curvedportion of the outer sidewall having one or more detachable interferenceribs 176 protruding radially outward towards the central axis locatedaround the outer circumference, the proximal end of the inner sidewallhaving one or more inwardly protruding tabs 178. A needleless IVconnector 180 is disposed in the open central cavity 168 of the innersidewall and held between the one or more inwardly protruding tabs 178of the inner sidewall.

A keying element 340 includes a housing having a sidewall 342 having acurved shape with a flat ledge 344 on a top portion, the sidewall 342having an open distal end 346 and a proximal end 348 having a back wall350. One or more detachable protrusions 352 extend radially outwardalong an outer circumference of the curved portion of the sidewall. Theback wall 350 includes an open central cavity 354.

As shown in FIG. 10, the one or more detachable interference ribs 176 ofthe locking element may be selectively configured to form gaps 178 in apattern to correspond with an individual patient and the detachableprotrusions of the keying element being selectively configured tocomplement the gaps 182 formed on the locking element.

The sidewall of the keying element 340 has a diameter smaller than thediameter of the outer sidewall of the locking element 320 to enable thekeying element to slide into the locking element when the flat ledge 166on a top portion and gaps 178 of the locking element are aligned withthe flat ledge 344 and protrusions 352 of the keying element.

Each individual patient is assigned a specific positioning for the gaps178 formed between the detachable interference ribs 176 of the lockingelement and the protrusions 352 on the keying element. It may bedesirable to design unique corresponding patterns of protrusions anddepressions, so that each locking element is unique to every otherkeying element. It may also be desirable to provide at least twoprotrusions that are unique to each keying element.

Upon assembly, the needleless IV connector 180 is positioned into theopen central cavity 168 of the inner sidewall of the locking element andinserted into the central cavity until the needleless IV connector isdisposed in the open central cavity of the inner sidewall and heldbetween the one or more inwardly protruding tabs 178 of the innersidewall of the locking element. The detachable interference ribs 176 ofthe locking element are configured to form a specific pattern of gapsthat has been assigned to the individual patient. The locking element320 is now assembled. The locking element 320 is placed onto a drugdelivery device or fluid container.

Similarly the detachable protrusions 352 of the keying element areconfigured to form a complementary pattern that corresponds with thespecific pattern of gaps formed on the locking element that is assignedto the individual patient. The keying element 340 is now ready to beplaced onto an IV access device on the patient.

The detachable interference ribs of the locking element and thedetachable protrusions of the keying element may be assigned a numericalvalue that may be imprinted in the outside surface of the outer housingof the locking element and keying element so that it is visible to thepharmacist and the medical care provider.

To deliver medication from the drug delivery device into the IV accessdevice on the patient, the flat ledge 166 on a top portion of thelocking element 320 is aligned with the flat ledge 344 on a top portionof the keying element 340. If the proper locking element 320 isdelivered to the patient, the specific pattern of gaps 182 formed on thelocking element 320 by removing a specific sequence of interference ribs176 will also align with the complementary pattern of protrusions 352 ofthe keying element 340 allowing the locking element 320 to properlyengage the keying element 340 so the IV access device engages theneedleless IV connector 180 of the locking element thus allowingmedication to flow from the drug delivery device to the patient. Howeverif the proper locking element 320 is not delivered to the patient, thespecific pattern of gaps 182 formed on the locking element will notalign properly with the protrusions 352 of the keying element thuspreventing the locking element 320 to properly engage the keying element340, thereby preventing the IV access device to engages the needlelessIV connector of the locking element thus preventing medication to flowfrom the drug delivery device to the patient.

When medication is to be prescribed to the patient, the doctor places anorder with the pharmacy regarding the type of medication to be deliveredto the patient. The pharmacy fills the order and configures a lockingelement 320 to the corresponding patient by removing or cutting thesequence of interference ribs 176 on the locking element to correspondto the depressions 182 formed by removing a particular sequence ofprotrusions 352 in the corresponding keying element.

In one or more embodiments, if an emergency exists, a master keyingelement may be used to unlock keying element 340.

In one or more embodiments, the present invention allows for keying notonly per patient but per application. Keying can also be coded to bedrug-family specific. The drug delivery safety device and systemdescribed in the present invention can be added to off-the-shelf drugdelivery devices and IV access devices. The drug delivery safety deviceand system described in the present invention can also be added tosyringes and IV access devices at the time of manufacture, whichsimplifies and reinforces their use in the clinical setting.

Cutter

In another embodiment of the present invention, as shown in FIGS. 11 and12, a cutter 400 containing multiple blades 410 affixed to differentlevers 420 housed in a cutter body 430. The blades 410 can be optionallyselected for use readily using a slidable lever 420 or turnable knob 440having a projected edge in cam contact with the top end of theblade-affixed levers. The top end of the desired blade-affixed lever 420is pushed downward for use, or in an alternate embodiment, the turnableknob 440 is rotated, so to enable a person to select a desired bladequickly and readily. The hollow interior of said cutter body 430 isfilled with numerous blade-affixed levers. A spring may be compressed inthe body for allowing the blade-affixed lever to project out of thedistal end of said cutter body for use. The multiple blade-affixed leverare separated from each other to allow a user to freely select differentblades. Each lever/projection may be individually numbered to allow theuser to select the proper sequence/pattern of blades to configure thecorresponding ribs to create the unique keying code.

Referring to FIG. 12, the multiple blade-affixed lever 460 disposed inthe cutter body are in a releasing relationship with the turnable knob440. When the turnable knob 440 is rotated, the desired blade-affixedlever 460 begins to come into contact with a cam which gradually movesthe blade-affixed lever downward until the blade projects forward in thebody and into a position to allow the blade to cut a desired protrusionor interference rib from a locking element or keying element. Theturnable knob 440 has its outer surface denticulated for easy operationof the knob without slipping as shown in FIG. 12.

When the cutter is not in use, the turnable knob is turned to releasethe downwardly pushed lever/projection to move out of the open distalend and retract into the cutter body along with the lever/projection.

Reference throughout this specification to “one embodiment,” “certainembodiments,” “one or more embodiments” or “an embodiment” means that aparticular feature, structure, material, or characteristic described inconnection with the embodiment is included in at least one embodiment ofthe invention. Thus, the appearances of the phrases such as “in one ormore embodiments,” “in certain embodiments,” “in one embodiment” or “inan embodiment” in various places throughout this specification are notnecessarily referring to the same embodiment of the invention.Furthermore, the particular features, structures, materials, orcharacteristics may be combined in any suitable manner in one or moreembodiments.

Although the invention herein has been described with reference toparticular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles and applications of thepresent invention. It will be apparent to those skilled in the art thatvarious modifications and variations can be made to the method andapparatus of the present invention without departing from the spirit andscope of the invention. Thus, it is intended that the present inventioninclude modifications and variations that are within the scope of theappended claims and their equivalents.

What is claimed is:
 1. A drug delivery safety device comprising: alocking element having a body with a proximal end and a distal end, theproximal end being attachable a drug delivery device and the distal endof the locking element having at least one flange with a plurality ofmechanically configurable sections to provide a patient specific patternof receiving openings; a keying element having a proximal end and distalend, the proximal end attachable to a vascular access device, and thedistal end having a plurality of mechanically configurable engagementmembers; wherein the drug delivery device securely connects to thevascular access device when the engagement member of the keying elementis configured to provide a complementary fit with the patient specificpattern of receiving openings of the locking element.
 2. The drugdelivery safety device of claim 1 wherein the drug delivery device is asyringe, intravenous catheter connector, IV bag spike, or point ofinterconnection in an IV administration set.
 3. The drug delivery safetydevice of claim 2 wherein the drug delivery device is a syringe having atip located in the body of the locking element.
 4. The drug deliverysafety device of claim 1 wherein the mechanically configurable sectionscomprise a plurality of configurable notches.
 5. The drug deliverysafety device of claim 4 wherein the plurality of configurable notchesincorporate predetermined geometrical shapes.
 6. The drug deliverysafety device of claim 5 wherein the configurable notches are on theperiphery of the flange.
 7. The drug delivery safety device of claim 1wherein an end user may remove, move, rotate, reshape, melt, reposition,uncover, or puncture one or more of the plurality of mechanicallyconfigurable sections.
 8. The drug delivery safety device of claim 7wherein the locking element is configured to be patient specific.
 9. Thedrug delivery safety device of claim 7 wherein the locking element isconfigured to be application specific.
 10. The drug delivery safetydevice of claim 7 wherein the locking element is configured to be drugspecific.
 11. The drug delivery safety device of claim 1 wherein theflange has a circular shape.
 12. The drug delivery safety device ofclaim 1 wherein the locking element has two flanges.
 13. The drugdelivery safety device of claim 1 wherein the keying element isrotatable.
 14. The drug delivery safety device of claim 13 wherein thekeying element is spring-loaded.
 15. The drug delivery safety device ofclaim 1 wherein the locking element further comprises a sensor.
 16. Thedrug delivery safety device of claim 1 wherein the keying elementfurther comprises a sensor.
 17. The drug delivery safety device of claim1 wherein the engagement members comprise removable tab-like projectionsto identify an individual patient, application or drug type.
 18. Thedrug delivery safety device of claim 1 further comprising a visualindicator for drug family identification.
 19. The drug delivery safetydevice of claim 1 wherein the locking element and keying element areassociated with only one patient or small number of patients of a largerpatient population.
 20. The drug delivery safety device of claim 1further including a master keying element capable of unlocking two ormore individualized locking elements.
 21. The drug delivery safetydevice of claim 5 wherein an end user may configure a selected number ofnotches to create a locking element to distinguish the route ofadministration.
 22. The drug delivery safety device of claim 21 whereinthe route of administration is parenteral, enteral or anesthesia.
 23. Adrug delivery safety device comprising: a locking element comprises ahousing having a curved-shaped outer sidewall with a flat ledge on a topportion, an inner sidewall having an open central cavity, a back walllocated between the inner and outer sidewalls; the inner sidewall havinga distal end and a proximal end, the distal end having one or moredetenting ribs protruding radially outward around the outercircumference, the proximal end of the inner sidewall having one or moreinwardly protruding tabs; a needleless IV connector disposed in the opencentral cavity of the inner sidewall and held between the one or moreinwardly protruding tabs of the inner sidewall; a first insert having anopen distal end and an open proximal end; a sidewall extending betweenthe open distal end and the open proximal end, the sidewall on thedistal end having more than one detents on an inside circumference ofthe sidewall protruding radially inward toward the central axis, the oneor more detents of the first insert having a complimentary fit with theone or more detenting ribs of the housing when the first insert is placeinto the housing; a keyway cut into the sidewall on the proximal end ofthe first insert to correspond with an individual patient; a keyingelement comprising a housing having a outer sidewall having a curvedshape with a flat ledge on a top portion, the outer sidewall having anopen distal end and a proximal end having a back wall, an inside surfaceof the proximal end of the outer sidewall having one or more detentslocated around the circumference of the inside surface of the proximalend of the outer sidewall protruding radially outward, the back wallhaving an open central cavity formed by a second inner wall; a secondinsert having an open distal end and an open proximal end; a sidewallextending between the open distal end and the open proximal end, thesidewall on the proximal end having one or more detenting ribs on anouter circumference of the sidewall protruding radially outward, the oneor more detenting ribs of the second insert having a complimentary fitwith the one or more detent of the housing when the second insert isplace into the housing, a key tab projecting radially inward from thedistal end of the second insert toward the central axis; the outersidewall of the keying element having a diameter smaller than the outerdiameter of the outer sidewall of the locking element to enable thekeying element to slide into the locking element when the keyway of thelocking element is aligned with the tab projecting radially inward fromthe distal end of the second insert.
 24. The drug delivery safety deviceof claim 23 wherein the locking element is placed on a drug deliverydevice.
 25. The drug delivery safety device of claim 24 wherein the drugdelivery device is a syringe.
 26. The drug delivery safety device ofclaim 23 wherein the keying element is placed on a intravenous accessdevice.
 27. The drug delivery safety device of claim 23 wherein theposition of the keyway and key tab is patient specific.
 28. The drugdelivery safety device of claim 23 wherein the position of the keywayand key tab is specific to a route of administration.
 29. The drugdelivery safety device of claim 23 wherein the position of the keywayand key tab is specific to a drug class.
 30. The drug delivery safetydevice of claim 23 further comprising a visual indicator for drug familyidentification.
 31. The drug delivery safety device of claim 23 whereinthe housing of the locking element is imprinted with numerical valuesassigned to different positions of the keyway.
 32. The drug deliverysafety device of claim 23 wherein the housing of the keying element isimprinted with numerical values assigned to different positions of thekey tab.
 33. A drug delivery safety device comprising: a locking elementcomprises a housing having an outer sidewall, an inner sidewall, a backwall located between the inner and outer sidewalls; the outer sidewallhaving a curved shape with a flat ledge on a top portion, the innersidewall creating an open central cavity, the inner sidewall having adistal end and a proximal end, the inside surface of the curved portionof the outer sidewall having one or more detachable interference ribsprotruding radially outward towards the central axis, the proximal endof the inner sidewall having one or more inwardly protruding tabs; aneedleless IV connector disposed in the open central cavity of the innersidewall and held between the one or more inwardly protruding tabs ofthe inner sidewall; a keying element comprising a housing having asidewall having a curved shape with a flat ledge on a top portion, thesidewall having an open distal end and a proximal end having a backwall; one or more detachable protrusions extending radially outwardalong an outer circumference of the curved portion of the sidewall; theback wall having an open central cavity; the one or more detachableinterference ribs of the locking element being configurable to form gapsin a pattern to correspond with an individual patient and the detachableprotrusions of the keying element being configurable to complement thegaps formed on the locking element; the sidewall of the keying elementhaving a diameter smaller than the diameter of the outer sidewall of thelocking element to enable the keying element to slide into the lockingelement when the gaps of the locking element are aligned with theprotrusions of the keying element.
 34. The drug delivery safety deviceof claim 33 wherein the locking element is placed on a drug deliverydevice.
 35. The drug delivery safety device of claim 34 wherein the drugdelivery device is a syringe.
 36. The drug delivery safety device ofclaim 33 wherein the keying element is placed on a intravenous accessdevice.
 37. The drug delivery safety device of claim 33 wherein theposition of the protrusions on the keying element is patient specific.38. The drug delivery safety device of claim 33 wherein the position ofthe protrusions on the keying element is specific to a route ofadministration.
 39. The drug delivery safety device of claim 33 whereinthe position of the protrusions on the keying element is specific to adrug class.
 40. The drug delivery safety device of claim 33 furthercomprising a visual indicator for drug family identification.
 41. Thedrug delivery safety device of claim 33 wherein the housing of thelocking element is imprinted with numerical values assigned to differentdetachable interference ribs.
 42. The drug delivery safety device ofclaim 23 wherein the housing of the keying element is imprinted withnumerical values assigned to different detachable protrusions.